The Effects of a Walking Program on Balance, Falls and Well Being in Individuals Residing in Long-term Care

This study is ongoing, but not recruiting participants.

Sponsor:

University of Saskatchewan

ClinicalTrials.gov Identifier:

NCT01277809

First Posted: January 17, 2011

Last Update Posted: June 23, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to assess the effectiveness of a regular walking program (which inevitably involves human interaction) compared to a usual care condition and to a human interaction condition (without the extra walking program) in individuals residing in Long-Term Care (LTC). Outcomes of interest include: balance, strength, mobility, endurance, walking distance; rate and severity of falls; activities of daily living; mood and behaviour.

It is hypothesized that participants taking part in the walking program will demonstrate maximal benefits compared to the no treatment control group (usual care) and the participants who will only receive social interaction. It is expected that benefits of the walking program will include decreased fall rates, and improved balance, endurance, strength, mood, behaviour, activities of daily living and quality of life indices. Given research findings that the addition of pleasant activities improves resident mood (Teri et al, 1997; 2003), it is expected that participants in the social interaction only group will demonstrate improvements in mood and other indices of quality of life.

Further study details as provided by Lilian Thorpe, University of Saskatchewan:

Primary Outcome Measures:

Falls [ Time Frame: Eight months ]

The incidence and nature of falls will be prospectively collected using a simple daily Fall Diary for the period of the intervention (4 months) and for 4 months following intervention. The Fall Diary will be kept at the residents' bedside and will staff will be asked to record the nature and location of the fall, activity and symptoms at the time of the fall, type of footwear, injuries resulting from the fall. Diaries will be collected every week by study personnel.

The Berg Balance Scale will be used to objectively assess a person's ability to safely perform several common daily living tasks

Grip Strength [ Time Frame: Eight months ]

Grip strength of the dominant and non-dominant hand-held dynamometer will be measured. Strength will be tested 3 times with each hand and the maximum score will be recorded

Gait speed [ Time Frame: Eight months ]

Participants will be asked to walk a distance of 6 metres over a portable, computerized walkway (the GAITRite® system (CIR Systems Inc., Clifton, NJ). An additional two metres of walking will be added at the beginning and end of the walkway to accommodate for acceleration and deceleration. Subjects will be asked to walk along the walkway. Gait parameters, including gait speed, will be recorded.

Physical Activities of Daily Living [ Time Frame: Eight months ]

OARS Physical Activities of Daily Living (PADL) Sub-Scale (Fillenbaum 1988)will be used as a clinical assessment of functional status. The OARS-PADL will be completed by the research assistant with information provided by subjects' care provider.

Depression [ Time Frame: Eight months ]

Mood will be assessed using the Cornell Scale for Depression in Dementia, a well- validated scale designed for the assessment of depression in individuals with dementia and individuals residing in long-term care. The CSDD will be completed by the research assistant with information provided by subjects' care provider.

Behavioral problems [ Time Frame: Eight months ]

Behavioral problems will be assessed with the use of the Revised Memory and Behavior Problems Checklist (RMBPC), a 24-item report that measures observable behavioral and memory problems (Appendix). The RMBPC will be completed by the research assistant with information provided by subjects' care provider.

Vital signs [ Time Frame: Eight months ]

We will measure lying and standing blood pressure as well as heart rate and respiratory rate at baseline and every two months throughout the study.

Participants will receive care as usual (Usual Care Group; UCG) that is provided by their long-term care unit.

Active Comparator: Interpersonal Interaction

Participants will receive stationary 1:1 interaction time with the same research personnel who conduct the third group walking session at each individual care facility in order to control for the interpersonal interaction likely to be involved in the walking program. This group will receive the equivalent interpersonal interaction time with research personnel as those participating in the walking group. This interaction time will occur with the participant stationary, rather than walking with the researcher.

Behavioral: Interpersonal Interaction

Participants will receive stationary 1:1 interaction time with the same research personnel who conduct the third group walking session at each individual care facility in order to control for the interpersonal interaction likely to be involved in the walking program (Interpersonal Interaction Group; IIG). This group will receive the equivalent interpersonal interaction time with research personnel as those participating in the WPG group. This interaction time will occur with the participant stationary, rather than walking with the researcher.

Experimental: Walking Program

Participants will walk five times per week under the supervision of a licensed physiotherapist.

Behavioral: Walking Program

Participants will walk five times per week, supervised by a licensed physiotherapist. Subjects will in general gradually increase their daily supervised walking time as tolerated to a maximum of 30 minutes once per day. The distance and number of minutes walked each time will be recorded. Interpersonal interaction will occur during the walking sessions, and will be similar in quality and quantity to that during the Interpersonal Interaction Group.

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Ages Eligible for Study:

60 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Adults residing in a long term care facility

Able to follow simple instructions

Can ambulate with or without a walking aid for at least 10 meters

Willing to participate in the study procedures Exclusion Criteria:

Exclusion criteria:

Cardiovascular event within past 6 months

Severe arthritis

Clinical significant vestibular disorder

Uncontrolled hypertension

Uncontrolled epilepsy

Fracture within the past 4 months

Admission into an acute care facility in last 4 months

Scheduled for surgery or hospitalization in next 6 months

Already participating in another regular exercise program (three or more times per week) aimed at improving balance or strength

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277809